A Study of ARRY-380 in Patients With Advanced HER2+ Cancer

Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650572
• Other study ID #: ARRAY-380-101
• Status: Completed
• Phase: Phase 1
• Start date: May 2008
• Est. completion date: March 2013

Study information

• Verified date: May 2020
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1 study during which patients with advanced HER2+ solid malignancies or HER2+ metastatic breast cancer will receive investigational study drug ARRY-380.

This study has 2 parts. In the first part, patients with advanced HER2+ solid malignancies, who have already received at least one previous standard therapy, will receive increasing doses of study drug in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Completed).

In the second part of this study, patients with HER2+ metastatic breast cancer, who have already received at least one previous standard therapy, will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 20 patients from the US will be enrolled in Part 2 (Active, not recruiting).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria (Part 1 and Part 2):

• Histological or cytological evidence of HER2+ cancer (Part 1) or HER2+ metastatic breast cancer (Part 2).

• Patients should have received at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy (patients with HER2+ breast cancer and with clinical indication for trastuzumab or lapatinib should have received prior therapy with trastuzumab and lapatinib, if available).

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.

• Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

• Uncontrolled or symptomatic brain metastases (patients may be considered adequately controlled if on a stable steroid dose for at least 30 days).

• Treatment with an investigational medicinal product or device within 30 days prior to first dose of study drug.

• Radiotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).

• Chemotherapy within 21 days prior to first dose of study drug.

• Major surgery within 30 days prior to first dose of study drug.

• Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.

• Additional criteria exist.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• ARRY-380, HER2 inhibitor; oral
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.

Locations

Country	Name	City	State
Canada	Cancer Centre of Southeastern Ontario at Kingston General Hospital	Kingston	Ontario
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
United States	The University of Colorado Cancer Center	Aurora	Colorado
United States	The University of Texas, MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.	Array BioPharma

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.		Part 1, one year; Part 2, one year
Primary	Establish the maximum tolerated dose (MTD) of the study drug.		Part 1, one year
Primary	Characterize the pharmacokinetics of the study drug.		Part 2, one year
Primary	Assess amplification/expression of HER2 in archival and tumor tissues.		Part 2, one year
Secondary	Characterize the pharmacokinetics of the study drug.		Part 1, one year
Secondary	Assess changes in tumor markers.		Part 1, one year
Secondary	Assess the efficacy of study drug in terms of tumor response and duration of response.		Part 1, one year; Part 2, one year
Secondary	Assess expression of growth factor pathway proteins in archival and tumor tissues.		Part 2, one year